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Essential Functions

In this position, you are responsible for performing Quality Control (QC) testing activities, including incoming material testing, in-process testing, lot release testing, stability, and complaints. You are also responsible for laboratory material control, laboratory equipment qualifications and executing method validations, and Contract Manufacturing testing and method transfer activities. You'll work closely with cross-functional team members to ensure alignment with Quality Systems. In your role, you'll also work closely with other Chemists, Quality Assurance, and other departments. This position reports to the Quality Control Manager.

About Us

Vivani is an innovative, near-clinical stage biopharmaceutical company located in Alameda, CA. Leveraging our proprietary NanoPortal platform technology, we are developing a portfolio of miniature, long-term drug implants to address two main barriers of optimal chronic disease treatment: medication non-adherence and tolerability. Our lead asset, NPM-119, is a miniature, 6-month, subdermal, GLP-1 implant under development for type 2 diabetes and/or obesity. Come join us!

Significant Duties and Responsibilities

• Hands-on analytical testing of GXP material.
• Troubleshooting/maintaining analytical equipment.
• Support the validation implementation of QC methods for drug substances, drug product, intermediates, starting materials, excipients, and packaging materials and components.
• Perform QC peer review/approval of analytical test data for drug substance/product batch release and stability test data.
• Perform stability activities, assist in compiling/analyzing stability data/reports and perform data trending.
• Initiate OOS/OOT investigations and other non-conforming investigations.
• Review/approve controlled GMP documents, e.g., analytical methods and associated validation protocols, reports, specifications, change controls, investigations, etc.
• Review development reports for data integrity and regulatory compliance; review/author CMC content incorporated into regulatory submissions.
• Compile/archiving data packages, protocols, reports, methods etc.
• Support testing by contract laboratories and contract manufacturers.
• Maintain and calibrate laboratory equipment.
• Support effective communication and deliver QC objectives in accordance with project timelines.
• May perform additional duties as needed.
• This is an onsite position, with remote work from time to time

Requirements

Minimum Education

• BS in Chemistry or equivalent.
• Minimum 2 years in a pharmaceutical QC laboratory
• Validations incorporating Part 11.

Minimum Experience

• Minimum 2 years in a pharmaceutical QC laboratory
• Validations incorporating Part 11.

Skills and competencies

• HPLC expertise using Thermo Fisher (Dionex) or Agilent, including reverse phase and normal phase.
• Analysis using standard testing equipment (Karl Fischer, pH meter, etc.)
• Statistical analysis using JMP or Minitab
• Expert in Excel, preparing formulas and graphs.
• Author protocols/reports for Analytical equipment validation and method validations.

Preferred Education, Skills, and Certifications

• Education: Masters Degree in Chemistry or related discipline
• Experience using Chromeleon software
• Certification: ASQ Quality Auditor or Quality Engineer
• Certification: Six Sigma Green Belt

Physical Demands and Working Conditions

• May be required for extended times to stand, walk, sit, reach with hands and arms, balance, or stoop.
• Requires fine motor skills and dexterity.
• Ability to lift up to 25 lbs.
• Must be able to pass a vision test for a California driver's license (prescription lenses are acceptable)

Working Conditions

• Working in close quarters with others
• Work in laboratory and hoods were fumes may be present
• Laboratory may contain toxic chemicals.
• PPE is required.
• Biohazard area which requires bloodborne pathogen training
• Safety training required
• This role may require weekend work or travel, if applicable

Must be legally authorized to work in the US.

Salary range: $68K - $164K DOE

Benefits

• Medical - choice of PPO or HMO
• Dental, Vision, and Employee Assistance Plan
• Flexible Spending Account
• 401K with a Company Safe Harbor match of up to 4% match
• Basic life insurance
• Long Term Disability
• Home office stipend
• Commuter benefits for those taking public transportation to/from work